NCT00436098

Brief Summary

Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 27, 2008

Status Verified

August 1, 2008

Enrollment Period

2.8 years

First QC Date

February 15, 2007

Last Update Submit

August 26, 2008

Conditions

Heart Defects, Congenital

Keywords

congenital heart diseaseexercise trainingmotorpedagogical exercisechildrenCHD: hemodynamically not significant defectsCHD: acyanotic defects after repairCHD: cyanotic defects after repair

Outcome Measures

Primary Outcomes (1)

  • Activity: triaxial accelerometry

    3 months

Secondary Outcomes (3)

  • coordinative test: MOT 4-6

    3 months

  • coordinative test: LOS KF 18

    3 months

  • Quality of life: Kiddy-KINDL

    3 months

Study Arms (2)

1

EXPERIMENTAL

physical training

Behavioral: Motorpedagogic exercise

2

NO INTERVENTION

Interventions

Motorpedagogic exerciseBEHAVIORAL

physical training

1

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • without significant residuals hemodynamically not significant
  • without significant residuals after repair
  • age 4-6 incl.

You may not qualify if:

  • gradient at coarctation site \> 20 mmHg
  • gradient RVOT, PV, LVOT, or AoV \> 30 mmHg
  • right-left shunt (rest or exercise)
  • left-right shunt with dilatation or failure of ana cardiac chamber
  • pulmonary hypertension
  • heart failure, necessitating therapy
  • (suspected) myocarditis or cardiomyopathy
  • significant arrhythmia
  • ion channel defects, other arrhythmic diseases
  • Fontan-like circulation
  • repair by atrial switch
  • oral anticoagulation
  • other medical problems curtailing exercise capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, D-80636, Germany

RECRUITING

Kuratorium für Prävention und Rehabilitation der TU München

Munich, D-80809, Germany

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alfred Hager, MD

    Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfred Hager, MD

CONTACT

+49-89-1218a-hager@web.de

Milka Pringsheim, MD

CONTACT

+49-89-1218pringsheim@dhm.mhn.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 16, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2009

Study Completion

May 1, 2010

Last Updated

August 27, 2008

Record last verified: 2008-08

Locations

DE(2)